FDA WARNING_LETTER - cigarettstore.com

The FDA's Center for Tobacco Products reviewed http://www.cigarettstore.com and found cigarette products offered for sale in the U.S. that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). These products are subject to FDA jurisdiction. The firm's products are adulterated under section 902(8) of the FD&C Act because they are modified risk tobacco products (MRTPs) sold or distributed without a required FDA order. This includes products described as "light," "ultra light," or similar descriptors in labeling or advertising, or those making implicit claims of reduced risk or exposure, violating section 911(a) and 911(b)(2)(A)(ii). Additionally, several cigarette products are adulterated under section 902(5) or misbranded under section 903(a)(1) or 903(a)(7)(A) because they purport to contain an artificial or natural characterizing flavor (other than tobacco or menthol), which is prohibited for cigarettes under section 907(a)(1)(A). Examples include "Aroma Rich Apple" and "Kiss Super Slims Clubnichka 100s (strawberry)." The FDA requires immediate correction of these violations and similar deficiencies to ensure full compliance with the FD&C Act. A written response detailing corrective actions, including discontinuation dates and a compliance plan, must be submitted within 15 working days. Failure to comply may result in severe enforcement actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and import refusal.